SPADA Docs

identifying genetic and physical changes that might have resulted from laboratory handling and 66 could impact the validity of an extensible study. 67 ( h ) Application-oriented testing is designed to assess the relationship between the test and 68 index cultures with respect to the specific genotypic or phenotypic phenomena being evaluated 69 in the extensible study. For example, if the study relates to microbial virulence, some effort 70 should be made to show that the virulence of the test strain resembles that of the index strain. 71 ( i ) Culture verification statements provide a convenient mechanism for documenting the 72 relatedness of microbial cultures used in extensible studies. 73

4.0 Roles and Responsibilities

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An extensible study’s sponsor, culture producer, and performer have distinct roles and 75 responsibilities with respect to the culture verification process. Each of these roles and their 76 associated responsibilities are described below and can be filled by the same or different 77 organizations. 78

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4.1 Study Sponsor

The sponsor is the entity that defines the study’s objectives. The sponsor’s principal 80 responsibilities with respect to culture verification are to approve the index cultures to which 81 each of the test cultures must relate and to determine the acceptable level of relatedness. These 82 responsibilities are generally accomplished by specifying the culture producer and lot number (or 83 equivalent designator) of each of the study’s index cultures and ruling on the adequacy of 84 performer-supplied culture verification statements. 85 When selecting index cultures and approving culture verification statements, the sponsor 86 should be aware of how their decision will impact project costs. Limited availability of singled- 87

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